Trial Outcomes & Findings for Sleep Device Testing to Promote Sleep in Infants (NCT NCT05078112)

Last Updated: 2024-10-15

Results Overview

Parents reported number of nighttime awakenings on the 5 days immediately prior to intervention (at baseline) and 5 days immediately following the intervention. The intervention takes place during the 20 days in between the measurement of baseline measures and post-intervention measures. The number of nighttime awakenings is averaged over the 5 days prior to intervention and compared to the average over 5 days after intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

Baseline to 5 days post-intervention

Results posted on

2024-10-15

Participant Flow

Participants were recruited from the Duke Pediatric outpatient clinics from October 2021 to June 2022.

Participant milestones

Participant milestones
Measure	Sleep Device Intervention Infants will utilize the sleep device during sleep for 20 days. Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleep Device Testing to Promote Sleep in Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sleep Device Intervention n=19 Participants Infants will utilize the sleep device during sleep for 20 days. Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.
Age, Continuous	6.2 months STANDARD_DEVIATION 2.2 • n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	19 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline to 5 days post-intervention

Outcome measures

Outcome measures
Measure	Sleep Device Intervention n=19 Participants Infants will utilize the sleep device during sleep for 20 days. Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.
Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary	-0.88 awakenings per night Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline to post-intervention (approximately 20 days)

Population: Caregivers were not considered enrolled, but did contribute to this assessment. Each caregiver that had pre and post-intervention BISQ-SF scores available contributed to this assessment.

The BISQ-SF is a research tool that measures infant sleep metrics, parental perceptions of the child's sleep, and parental behaviors. The total score is scaled from 0 to 100, with higher scores denoting better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep.

Outcome measures

Outcome measures
Measure	Sleep Device Intervention n=34 Participants Infants will utilize the sleep device during sleep for 20 days. Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.
Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score	13.4 score on a scale Standard Deviation 10.6

SECONDARY outcome

Timeframe: Baseline to post-intervention (approximately 20 days)

Population: Caregivers were not considered enrolled but did contribute to this assessment. Each caregiver that had pre and post-intervention ESS scores available contributed to this assessment.

Caregivers evaluate their own sleepiness via the ESS. The ESS has a total score range of 0 to 24, where a higher score indicates greater sleepiness.

Outcome measures

Outcome measures
Measure	Sleep Device Intervention n=34 Participants Infants will utilize the sleep device during sleep for 20 days. Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.
Change in Caregiver Epworth Sleepiness Scale (ESS)	-0.94 score on a scale Standard Deviation 2.95

SECONDARY outcome

Timeframe: Baseline to post-intervention (approximately 20 days)

Population: Caregivers were not considered enrolled but did contribute to this assessment. Each caregiver that had pre and post-intervention PHQ-2 scores available contributed to this assessment.

A PHQ-2 score ranges from 0 to 6, where a higher score indicates a greater frequency of depressed mood and anhedonia.

Outcome measures

Outcome measures
Measure	Sleep Device Intervention n=34 Participants Infants will utilize the sleep device during sleep for 20 days. Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.
Change in Patient Health Questionnaire-2 (PHQ-2) Score	-0.47 score on a scale Standard Deviation 1.16

Adverse Events

Sleep Device Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sujay Kansagra, MD

Duke University

Phone: 919-668-0477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place